Field of the Invention
The present invention relates to a portable medical device for communication of medical data information.
The present invention also relates to a method of communication of medical data information by a portable medical device.
Related Art
Product and software validation for medical products are troublesome, delays a product's time-to-market, time-consuming, complicates revision tasks, and is expensive.
For example, in some jurisdictions, regulatory bodies govern the approval of medical products (e.g., devices) according to preset validation standards for medical products. Likewise, regulatory bodies typically also govern the approval of any software contained within medical products according to preset validation standards for medical product software. For example, in the United States the Food and Drug Administration (FDA) has issued a document entitled, “Design Control Guidance for Medical Device Manufacturers,” on Mar. 11, 1997, which provides criteria for approval of medical product (e.g., device) design according to its established preset validation standards. Likewise, with regard to software, the FDA has issued a document entitled “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” on Jan. 11, 2002 (which supersedes an earlier document dated Jun. 9, 1997), which provides criteria for approval of software according to its established preset validation standards.
Medical products (e.g., devices) can further include communication parts (e.g., Bluetooth, Radio frequency (RF) communication, Infrared (IR) communication, HTTP (Hyper Text Transmission Protocol), SHTTP (Secure Hyper Text Transmission Protocol), TCP/IP (Transmission Control Protocol/Internet Protocol), PPP (Point-to-Point), SSL (Secure Socket Layer), TLS (Transport Layer Security), GSM (Global System for Mobile communication), GPRS (General Packet Radio System), UMTS (Universal Mobile Telephone System), and IrDA, among others) of which the general design and operation of the communication parts are governed and/or regulated by standards setting bodies which provide criteria for approval of communication parts according to established preset validation standards.
It has heretofore been known to fully integrate communication parts and software within the medical products, such that approval of each of the communication part, the medical product (e.g., device), and the software is required, each according to preset validation standards in their appropriate technology and/or jurisdiction. However, the full integration of the communication part or software within the medical product can require renewed approval of the entire medical product (i.e., device and software) if any revisions are made to either the communication part, medical product (e.g., device) itself, or any software contained in the medical product. Thus, revisions of either the communication part, medical product (e.g., device) or any software contained in the medical product can delay a product's time-to-market, be time-consuming, complicates revision tasks, and can be expensive.
Rapid development in the field of communication requires for frequent updates of communication soft-, hard- and/or firmware in a medical device. As a result medical product and software validation is required for a medical device with updated communication means even though no changes have been made to the medical application “part” of the device.